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Binimetinib - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for binimetinib and what is the scope of patent protection?
Binimetinib
is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Binimetinib has two hundred and twenty-two patent family members in fifty-three countries.
One supplier is listed for this compound.
Summary for binimetinib
| International Patents: | 222 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 71 |
| Clinical Trials: | 52 |
| Patent Applications: | 201 |
| DailyMed Link: | binimetinib at DailyMed |
Recent Clinical Trials for binimetinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 2 |
| Southwest Oncology Group | Phase 2 |
| Pierre Fabre Ibérica, S.A. | Phase 1/Phase 2 |
US Patents and Regulatory Information for binimetinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for binimetinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Dominican Republic | P2003000613 | Start Trial |
| Slovenia | 2470526 | Start Trial |
| China | 100519539 | Start Trial |
| Hong Kong | 1070823 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for binimetinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | 7-2019 | Slovakia | Start Trial | PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 1482932 | 334 8-2019 | Slovakia | Start Trial | PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| 2470526 | C201930019 | Spain | Start Trial | PRODUCT NAME: ENCORAFENIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1314; DATE OF FIRST AUTHORISATION IN EEA: 20180920 |
| 1482932 | 19C1014 | France | Start Trial | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1315 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
